BNF for Children (BNFC) 2018-2019

(singke) #1

Valganciclovir 31-May-2018


lINDICATIONS AND DOSE
Prevention of cytomegalovirus disease [following solid
organ transplantation from a cytomegalovirus positive
donor]
▶BY MOUTH
▶Neonate:(consult product literature).

▶Child:(consult product literature)
DOSE EQUIVALENCE AND CONVERSION
▶Oral valganciclovir 900 mg twice daily is equivalent to
intravenous ganciclovir 5 mg/kg twice daily.

lCONTRA-INDICATIONSAbnormally low haemoglobin count
(consult product literature).abnormally low neutrophil
count (consult product literature).abnormally low platelet
count (consult product literature)
lCAUTIONSHistory of cytopenia.potential carcinogen
(including long-term carcinogenicity).potential teratogen
(including long-term teratogenicity).radiotherapy
lINTERACTIONS→Appendix 1 : valganciclovir
lSIDE-EFFECTS
▶Common or very commonAnaemia.anxiety.appetite
decreased.arthralgia.asthenia.bone marrow disorders.
chest pain.confusion.constipation.cough.depression.
diarrhoea.dizziness.dysphagia.dyspnoea.ear pain.eye
disorders.eye inflammation.eye pain.flatulence.
gastrointestinal discomfort.headache.hepatic function
abnormal.increased risk of infection.insomnia.
leucopenia.malaise.muscle complaints.nausea.
neutropenia.night sweats.pain.peripheral neuropathy.
renal impairment.seizure.sensation abnormal.sepsis.
skin reactions.taste altered.thinking abnormal.
thrombocytopenia.vomiting.weight decreased
▶UncommonAlopecia.arrhythmia.deafness.haematuria.
hallucination.hypotension.infertility male.oral
ulceration.pancreatitis.psychotic disorder.tremor.
visual impairment
lALLERGY AND CROSS-SENSITIVITYContra-indicated in
patients hypersensitive to ganciclovir, aciclovir, or
valaciclovir.
lCONCEPTION AND CONTRACEPTIONManufacturer advises
women of childbearing potential should use effective
contraception during and for at least 30 days after
treatment; men with partners of childbearing potential
should be advised to use barrier contraception during and
for at least 90 days after treatment.Ganciclovirmay cause
temporary or permanent inhibition of spermatogenesis—
impaired fertility observed inanimalstudies.
lPREGNANCYManufacturer advises avoid unless potential
benefit outweighs risk—teratogenicity observed with
ganciclovirinanimalstudies.
lBREAST FEEDINGManufacturer advises avoid—ganciclovir
present in milk inanimalstudies.
lMONITORING REQUIREMENTSMonitor full blood count
closely (severe deterioration may require correction and
possibly treatment interruption).
lPRESCRIBING AND DISPENSING INFORMATION
Valganciclovir is a pro-drug of ganciclovir.
Flavours of oral liquid formulations may include tutti-
frutti.
lHANDLING AND STORAGEManufacturer advises
reconstituted powder for oral solution should be stored in
a refrigerator ( 2 – 8 °C) for up to 49 days.
Caution in handlingValganciclovir is a potential teratogen
and carcinogen. Manufacturer advises caution when
handling the powder, reconstituted solution, or broken
tablets and avoid inhalation of powder; if contact with skin

or mucous membranes occurs, wash thoroughly with soap
and water; rinse eyes thoroughly with plain water.

lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral solution
Oral solution
CAUTIONARY AND ADVISORY LABELS 21
▶Valcyte(Roche Products Ltd)
Valganciclovir (as Valganciclovir hydrochloride) 50 mg per
1mlValcyte 50 mg/ml oral solution sugar-free| 100 mlP
£ 230. 32
Tablet
CAUTIONARY AND ADVISORY LABELS 21
▶Valganciclovir (Non-proprietary)
Valganciclovir (as Valganciclovir hydrochloride)
450 mgValganciclovir 450 mg tablets| 60 tabletP£ 865. 17 –
£ 1 , 081. 46
▶Valcyte(Roche Products Ltd)
Valganciclovir (as Valganciclovir hydrochloride) 450 mgValcyte
450 mg tablets| 60 tabletP£ 1 , 081. 46

ANTIVIRALS


Foscarnet sodium


lINDICATIONS AND DOSE
Cytomegalovirus disease
▶BY INTRAVENOUS INFUSION
▶Child (under expert supervision):Initially 60 mg/kg every
8 hours 2 – 3 weeks, then maintenance 60 mg/kg daily,
increased if tolerated to 90 – 120 mg/kg daily, if disease
progresses on maintenance dose, repeat induction
regimen
Mucocutaneous herpes simplex virus infections
unresponsive to aciclovir in immunocompromised
patients
▶BY INTRAVENOUS INFUSION
▶Child (under expert supervision): 40 mg/kg every 8 hours
for 2 – 3 weeks or until lesions heal

lUNLICENSED USENot licensed for use in children.
lCAUTIONSEnsure adequate hydration
lINTERACTIONS→Appendix 1 : foscarnet
lSIDE-EFFECTS
▶Common or very commonAggression.anaemia.anxiety.
appetite decreased.arrhythmias.asthenia.chest pain.
chills.confusion.constipation.coordination abnormal.
dehydration.depression.diarrhoea.dizziness.electrolyte
imbalance.fever.gastrointestinal discomfort.genital
discomfort (due to high concentrations excreted in urine).
genital ulceration (due to high concentrations excreted in
urine).haemorrhage.headache.hepatic function
abnormal.hypertension.hypotension.leucopenia.
malaise.muscle contractions involuntary.myalgia.
nausea (reduce infusion rate).neutropenia.numbness.
oedema.palpitations.pancreatitis.paraesthesia (reduce
infusion rate).peripheral neuropathy.proteinuria.renal
impairment.seizure.sepsis.skin reactions.
thrombocytopenia.tremor.urinary disorders.vomiting
▶UncommonAcidosis.angioedema.glomerulonephritis.
nephropathy.pancytopenia
▶Frequency not knownAnaphylactoid reaction.diabetes
insipidus.muscle weakness.myopathy.oesophageal
ulcer.QT interval prolongation.renal pain.renal tubular
acidosis.severe cutaneous adverse reactions (SCARs)
lCONCEPTION AND CONTRACEPTIONMen should avoid
fathering a child during and for 6 months after treatment.
lPREGNANCYManufacturer advises avoid.
lBREAST FEEDINGAvoid—present in milk inanimalstudies.

408 Viral infection BNFC 2018 – 2019


Infection

5

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